Indian pharmaceutical company Lupin Limited (BSE:500257) (NSE:LUPIN) announced on Thursday that it has received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL Single-dose Prefilled Syringe.
The product has been approved as bioequivalent to the reference listed drug (RLD), Phytonadione Injectable Emulsion, 1 mg/0.5 mL, of International Medication Systems Limited.
Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL Single-dose Prefilled Syringe is indicated for the treatment and prophylaxis of hypoprothrombinemia (low blood clotting) and vitamin K-deficiency.
FDA accepts Bayer's application for KERENDIA in chronic kidney disease without diabetes
Okami Medical receives FDA approval for expanded indication of LOBO Vascular Occluder
Kedrion to be honoured at Premier's Supplier Innovation Celebration
Zydus and MSN announce US launch of generic Adempas (Riociguat Tablets)
FDA approves second Reykjavik manufacturing suite for AVT02
Ractigen Therapeutics reports positive first-in-human data for RAG-18 in Duchenne muscular dystrophy
AnnJi Pharmaceutical's AJ201 advances into pivotal Phase 3 trial for SBMA
Teva reports new ecopipam data showing tic reduction in Tourette syndrome